Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)

Exact Sciences Corporation

Status: Completed

Conditions: Inflammatory Bowel Disease; Digestive System Diseases; Colonic Diseases; Colorectal Neoplasms; Colorectal Cancer

Treatments: Device: Stool Collection Kit

Study type: Observational

Funder types: Industry

Identifiers

NCT02503696

2014-05

Details and patient eligibility

About

The primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).

Enrollment: 697 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female 18 - 84 years of age, inclusive, who have been diagnosed with IBD.
• Willing to provide a stool sample ≤120 but ≥7 days after a surveillance colonoscopy, which was negative for cancer/dysplasia.
• Written informed consent document signed and dated by the subject.

Exclusion criteria

• Any condition that in the opinion of the investigator should preclude participation in the study.
• A history of aerodigestive tract cancer.
• Prior colorectal resection, except ileocolic resection in Crohn's disease patients.
• IBD limited only to the rectum.
• Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may have been, introduced into the subject.

Trial design

697 participants in 1 patient group

IBD

Description:

Subjects will be men and women, 18-84 years of age, inclusive, who have been diagnosed with IBD. Each with a screening colonoscopy resulting in normal findings.

Treatment:

Device: Stool Collection Kit